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CALERIE Phase II Ancillary: Metabolic

NCT02695511 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2016-03-01

No results posted yet for this study

Summary

The primary aim of this NIA sponsored ancillary study of phase 2 CALERIE is to measure whether metabolic adaptation lasts up to 2 years in response to a 25% calorie restriction in normal-weight and slightly overweight individuals. Energy metabolism (24-hour sedentary and sleeping) will be measured in a respiratory chamber. Other measures include the activities of the sympathetic nervous and thyroid axes, oxidative stress in lipids, protein and DNA, organ size by MRI and echocardiography, and posture allocation (time spent engaging in different activities and the energy expended during these activities), and activity temperament (the innate predilection for movement). This set of studies will allow assessment of whether the previously observed metabolic adaptation in response to 25% caloric restriction is long lasting (up to two years), associated with reduced thyroid and sympathetic activities and reduced oxidative damage. The studies of organ sizes (liver, spleen, kidney, heart, adipose and muscle) by MRI and echo (heart) is essential to determine whether the metabolic adaptation is related to decreased organ sizes or improved organ energy metabolism efficiency. The above described measures will be performed at baseline and after 1 and 2 years of a 25% caloric restriction in 50 non-obese humans and in 25 sex-, BMI- and age- matched subjects who will not engage in caloric restriction.

Conditions

  • Aging

Interventions

OTHER

Caloric restriction

25% caloric restriction below baseline energy requirement

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Pennington Biomedical Research Center

    lead OTHER

Principal Investigators

  • Eric Ravussin, PhD · Pennington Biomedical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
46 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02695511 on ClinicalTrials.gov